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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217656

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NDA 217656 describes ICOSAPENT ETHYL, which is a drug marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Onesource Specialty, Pharmobedient, Qilu, Teva Pharms Usa, Xiamen Lp Pharm Co, and Zydus Lifesciences, and is included in eleven NDAs. It is available from seventeen suppliers. Additional details are available on the ICOSAPENT ETHYL profile page.

The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There are twelve drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.

Summary for 217656

Tradename:	ICOSAPENT ETHYL
Applicant:	Zydus Lifesciences
Ingredient:	icosapent ethyl
Patents:	0

Suppliers and Packaging for NDA: 217656

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	217656	ANDA	Softgel Healthcare Private Limited	35916-1592	35916-1592-1	120 CAPSULE in 1 BOTTLE (35916-1592-1)
ICOSAPENT ETHYL	icosapent ethyl	CAPSULE;ORAL	217656	ANDA	Softgel Healthcare Private Limited	35916-1738	35916-1738-1	240 CAPSULE in 1 BOTTLE (35916-1738-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Apr 20, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1GM
Approval Date:	Apr 20, 2023	TE:	AB	RLD:	No

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